Why clinical trials matter for treating MBC
Facing a diagnosis of metastatic breast cancer is challenging to say the least, and brings many difficult decisions including which treatment options to pursue. Among the options to consider should be clinical trials, research studies done in humans that often involve some type of intervention, such as testing a new drug to treat MBC. Many people think that clinical trials are only used as a last resort when all other standard treatments have failed. However, clinical trials can be an option starting with your first line of treatment and at every progression.
How could a clinical trial benefit me?
Access to cutting-edge treatments & interventions at all stages of the disease.
Clinical trials often provide access to the newest therapies not yet available to the general public. These treatments may offer better outcomes, fewer side effects, or new ways to manage your cancer. Besides drugs to treat MBC, there are clinical trials that test other interventions such as diet, exercise, side effect management, and ways to track progression like new imaging or biomarker tests.
Increased medical attention.
Participating in a trial means you’ll receive close monitoring and more frequent check-ups from a team of experts dedicated to your care. This can provide a sense of reassurance and support during your treatment journey. You can keep your own oncologist during the trial, though you may seem them less frequently.
Contributing to progress.
By joining a trial, you’re not only potentially helping yourself but also contributing to research that could lead to better treatments for other women with metastatic breast cancer in the future. While this is important, your comfort with the treatment and care you’re receiving is more important and you can leave a clinical trial at any time.
Potential for improved outcomes.
Some research has shown that clinical trial participants may experience longer survival times, improved quality of life, and better control of their cancer compared to standard treatments.
Empowerment and hope.
Taking an active role in your treatment plan can be empowering. Clinical trials offer a sense of hope and the possibility of benefiting from the latest advancements in cancer research.
What are some things to know before enrolling in a clinical trial?
While the above are important advantages to clinical trials, you may be worried about being a “guinea pig” or being harmed due to the new drug. Clinical trials go through a rigorous process to protect patients, but sometimes there is very little known about how a new drug will act in humans, particularly in phase 1 clinical trials (more on phases below). While you will be monitored closely for side effects, there is a small possibility of being harmed by these new drugs. Learn more about safety in clinical trials.
Another common misconception is that if you are in the control group of a treatment trial, you won’t get any treatment (a placebo). However, it’s important to know that you will always receive at least the standard of care for MBC when you enroll in a treatment trial.
Finally, it’s important to ask all your questions about the clinical trial, discuss with trusted friends and/or family, and your oncologist. They can help you make the right decision for you. And remember that you can leave a trial at any time.
If you are considering a specific trial, here is a checklist of important information to make sure you understand before you enroll.
Where can I get more information on clinical trials?
The National Cancer Institute offers basic information on clinical trials including what they are, how they work, and what to expect. Read more.
Metastatic Trial Talk has a comprehensive and helpful site with information about clinical trials in MBC. Explore here.
How do I find clinical trials?
There are multiple ways to find clinical trials, including the following.
- Consult your physician/oncologist. If you have a second opinion oncologist, consult with them as well.
- Provide your information to a clinical trial matching service. This will help match you to clinical trial(s) and generally send updates when a new trial is available. Some services have an associated cost; however, Metastatic Trial Talk offers this service for free, and includes a search function as well. Get started.
- Search for clinical trials on your own. The most comprehensive site for searching is ClinicalTrials.gov. It includes all public and private clinical research trials in the US and some abroad. To use this tool:
- We recommend starting with “metastatic breast cancer” for the condition/disease.
- Click on “More Filters” to expand this section.
- Set Study Status to “Recruiting and not yet recruiting”.
Set location to “Current Location” or a zip code. “Current Location” allows you to define a radius in miles for how far you can/are willing to travel. - If you get too many results, you may limit your search further using other “Other terms”, which has a drop down menu. You can start typing a search criteria such as “triple negative” or “hormone receptor positive” or “HER2-positive” and it will fill in for you.
- After you find a study, check the inclusion criteria (characteristics you/your cancer has to have to be included in the study) and “exclusion criteria” (characteristics you/your cancer must NOT have in order to be included in the study).
Understanding Clinical Trial Phases
Here’s a simplified breakdown of the phases of clinical trials for MBC treatment. Keep in mind that each trial is unique. Think of it like climbing a staircase. Each phase builds on the last, with increasing knowledge about the treatment’s safety and effectiveness. However, it’s important to remember that not every treatment makes it to the next phase. In fact only 5.3% of cancer drugs that start in a phase 1 trial make it to FDA approval.
Phase 1
Imagine this as the “first test” of a new treatment in humans. Researchers are primarily focused on safety. They start with very small groups of people and gradually increase the dose to find the most effective dose with side effects that are manageable. Often this is known as the “maximum tolerated dose.”
Phase 2
Now that the researchers have an idea of a safe dose, researchers want to see if the treatment actually works for metastatic breast cancer. They’ll look for signs that the cancer is responding and gather more information about side effects. Safety is an important aspect of every phase of clinical trials.
Phase 3
This phase compares the new treatment to the current standard treatment for metastatic breast cancer. It involves larger groups of people and aims to determine if the new treatment is better, the same, or worse than what’s already available.
Phase 4
If a treatment passes the first three phases and is approved by the FDA, it enters this phase. Researchers continue to monitor the treatment’s long-term effects, benefits, and any rare side effects that may emerge over time.
